Aminophylline

Product NDC
71872-7374
11-digit product format
718727374
Labeler code
71872
Product ID
71872-7374_52bbd383-b044-8ae6-e063-6394a90aa16f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aminophylline
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA087242
Marketing category
ANDA
Marketing start
2005-05-10
Substance
AMINOPHYLLINE DIHYDRATE
Active strength
25 mg/mL
Pharmacologic classes
Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A087242-001AMINOPHYLLINEAMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRLD, RS1983-10-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRLD, RS1983-10-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRLD, RS1983-10-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRLD, RS1983-10-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRLD, RS1983-10-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-263f01610625f2…
2019-09-15 20:21 UTC2019-09A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Aminophylline
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMINOPHYLLINE DIHYDRATE25 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C229N9DX94Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1724668Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
52bbc6cd-4baf-7859-e063-6394a90ac87dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1d07c79-5983-427d-b6f5-df0550dcc598Product name420250325
7b1e3dc0-e6b1-4d5d-943b-99fdd948b5a2Product name120170302

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71872-7374-1Aminophylline10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION101
71872-7374-1Aminophylline1 in 1 BAGINJECTION, SOLUTION11

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMINOPHYLLINEAMINOPHYLLINEHF Acquisition Co LLC, DBA HealthFirst819207a2-0c37-b275-e053-2a91aa0afb362026-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087242
application number: ANDA087242
AminophyllineAMINOPHYLLINEMedical Purchasing Solutions, LLC52bbc6cd-4baf-7859-e063-6394a90ac87d2026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087242
application number: ANDA087242
ndc (product): 71872-7374
AminophyllineAMINOPHYLLINEHospira, Inc.9a663ef3-881f-48bd-2689-3713b24545c22026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087242
application number: ANDA087242
AminophyllineAMINOPHYLLINEProPharma Distribution3f000254-a9f1-c8c7-e063-6394a90aa33f2025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087242
application number: ANDA087242
AminophyllineAMINOPHYLLINEHenry Schein, Inc.9066bdd0-cb03-40ed-abfa-1b6fb1fff6072025-10-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087242
application number: ANDA087242
AminophyllineAMINOPHYLLINEHenry Schein, Inc.9a9dedc4-ce04-4b22-9922-81a215ff59ed2025-10-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087242
application number: ANDA087242
AMINOPHYLLINEAMINOPHYLLINEHF Acquisition Co LLC, DBA HealthFirst75c2fc3e-28ac-c1b1-e053-2991aa0aee9f2024-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087242
application number: ANDA087242
AminophyllineAMINOPHYLLINEMedical Purchasing Solutions, LLC6bca324f-6999-4c16-e053-2a91aa0aee452023-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087242
application number: ANDA087242

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1724668aminophylline 250 MG in 10 ML InjectionPSN52bbc6cd-4baf-7859-e063-6394a90ac87d1
172466810 ML aminophylline 25 MG/ML InjectionSCD52bbc6cd-4baf-7859-e063-6394a90ac87d1
1724668aminophylline (as aminophylline dihydrate) 250 MG per 10 ML InjectionSY52bbc6cd-4baf-7859-e063-6394a90ac87d1
1724668aminophylline 250 MG per 10 ML InjectionSY52bbc6cd-4baf-7859-e063-6394a90ac87d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71872-7374-1718727374011 VIAL, SINGLE-DOSE in 1 BAG (71872-7374-1) / 10 mL in 1 VIAL, SINGLE-DOSE2026-05-21NoNoCurrent